Delayed Surveillance Colonoscopy Following Piecemeal EMR

Condition(s) studied

Investigational drug(s) / intervention(s)

Colonoscopy after bowel cleansing: The procedure is performed by experienced endoscopists using high-definition white light and narrow-band imaging to carefully inspect the colon and assess the resection site. Biopsies are taken only if abnormal tissue or recurrence is suspected.

Study summary

This multicenter, prospective, randomized non inferiority trial, conducted at four Israeli hospitals, will evaluate whether a relaxed surveillance strategy after piecemeal endoscopic mucosal resection (pEMR) of large non pedunculated colorectal polyps (LNPCPs, ≥20 mm) is as safe and effective as the current standard intensive surveillance. Approximately 760 adults undergoing complete pEMR with margin ablation will be randomized 1:1 into:

Standard Surveillance: Colonoscopy at 6, 18, and 48 months

Relaxed Surveillance: Colonoscopy at 12 and 48 months

All colonoscopies will be performed using high definition white light and narrow band imaging, with biopsies obtained only if recurrence is suspected. The investigators hypothesize that a relaxed surveillance strategy will be non inferior to the current standard intensive surveillance. If non inferiority is demonstrated, the study may support guideline changes toward reduced surveillance frequency after pEMR with margin ablation, potentially decreasing patient burden and healthcare costs.

Eligibility

Primary outcome measure(s)

• Rate of residual/recurrent adenoma (RRA) at first and second surveillance colonoscopy. — From patient enrollment until the end of the 48 month follow up period

Trial sites (1)

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